Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00463190
Protocol/serial number
N/A
Study information
Scientific title
Effect of probiotics (Bio-Three®) in children's enterocolitis
Acronym
Study hypothesis
Probiotics have been shown to be effective in the treatment of these conditions. There are many mechanisms by which probiotics enhance intestinal health, including stimulation of immunity, competition for limited nutrients, inhibition of epithelial and mucosal adherence, inhibition of epithelial invasion and production of antimicrobial substances.
Hypothesis:
Probiotics medication (Bio-Three®) could inhibit gastrointestinal infection and reduce its inflammatory response in the intestine. We plan to explore the bacterial count (microbiology) and subsequent immune response in probiotic inhibition of enterocolitis in children.
Ethics approval
Institutional Review Board of Chang Gung Memorial Hospital, Taoyuan, Taiwan. Date of approval: 10/01/2006
Study design
Randomised, double-blind (subject, caregiver, investigator), placebo-controlled, parallel-assignment, safety/efficacy, single-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Enterocolitis
Intervention
Treatment group: Oral probiotics (Bio-Three®) 3 times daily for 7 days
Control group: Placebo 3 times daily for 7 days
Bio-three® contains a mixture of Bacillus mesentericus, Streptococcus faecalis and Clostridium butyricium. Total bacterial count: 1.5 x 10^8 colony forming units (cfu) per tablet.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
To determine whether probiotics medication Bio-Three® inhibits gastrointestinal infection and reduce its inflammatory response in the intestine. The following were assessed:
1. Clinical symptoms 2 days after medication
2. Microbiology study 3 days and one week after medication
The time and the consistency of every stool were recorded and the total hospital duration was calculated.
Severity of diarrhoea was evaluated according to the following parameters: number of stools, fecal consistency, the presence or absence of mucus, and blood in stools.
Secondary outcome measures
Other clinical symptoms/signs including fever, vomiting, dehydration, abdominal pain, bloating, daily dietary intake and appetite were also recorded for 7 to 10 days.
Overall trial start date
01/02/2006
Overall trial end date
30/11/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age: From 3 months to 12 years, both male and female children
2. Clinical symptom of diarrhoea less than 3 days
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. Severe abdominal distension with risk of bowel perforation
2. Risk of sepsis
3. Past history of surgical operation of gastrointestinal tracts
Recruitment start date
01/02/2006
Recruitment end date
30/11/2007
Locations
Countries of recruitment
Taiwan
Trial participating centre
5, Fu-Hsing Street
Taoyuan
333
Taiwan
Funders
Funder type
Industry
Funder name
Chang Gung Memorial Hospital (Taiwan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Maywufa Company Ltd (Taiwan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary